18456 Federal Register / Vol. 79, No. 63 / Wednesday, April 2, 2014 / Rules and Regulations 

■ a. Removing the entry in Table 1 for 

‘‘CHAPTER 1200–3–17 CONFLICT OF 

INTEREST’’ in its entirety; and 

■ b. Adding in numerical order a new 

entry in Table 1 for ‘‘CHAPTER 0400– 

30–17 CONFLICT OF INTEREST’’. 

The addition reads as follows: 

§ 52.2220 Identification of plan. 

* * * * * 

(c) * * * 

TABLE 1—EPA APPROVED TENNESSEE REGULATIONS

State citation Title/subject State effective 

date EPA approval date Explanation 

CHAPTER 0400–03–17 CONFLICT OF INTEREST 

Section 0400–30–17–.01 ........ Purpose and Intent ................ 9/23/2013 4/2/2014 [Insert citation of 

publication].

Section 0400–30–17–.02 ........ Protecting the Public Interests 9/23/2013 4/2/2014 [Insert citation of 

publication].

Section 0400–30–17–.03 ........ Conflict of Interest on the Part 

of the Board and Technical 

Secretary.

9/23/2013 4/2/2014 [Insert citation of 

publication].

Section 0400–30–17–.04 ........ Conflict of Interest in the Permitting of Municipal Solid 

Waste Incineration Units.

9/23/2013 4/2/2014 [Insert citation of 

publication].

Section 0400–30–17–.05 ........ Policy of Ethics and the 

Avoidance of Conflicts of 

Interest.

9/23/2013 4/2/2014 [Insert citation of 

publication].

* * * * * * * 

* * * * * 

[FR Doc. 2014–07240 Filed 4–1–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0056; FRL–9907–62] 

Clomazone; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of clomazone in 

or on multiple commodities which are 

identified and discussed later in this 

document. In addition, this regulation 

removes an existing tolerance on 

‘‘cabbage’’ that is superseded by this 

action. The Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

2, 2014. Objections and requests for 

hearings must be received on or before 

June 2, 2014, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0056, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2013–0056 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before June 2, 2014. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 


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Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0056, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

http://www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of Wednesday, 

February 27, 2013 (78 FR 13295) (FRL– 

9380–2), EPA issued a document 

pursuant to FFDCA section 408(d)(3), 21 

U.S.C. 346a(d)(3), announcing the filing 

of a pesticide petition (PP 2E8136) by 

the Interregional Research Project 

Number 4, IR–4 Project Headquarters, 

500 College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.425 be 

amended by establishing tolerances for 

residues of the herbicide clomazone, 2- 

[(2-chlorophenyl)methyl]-4,4-dimethyl3-isoxazolidinone, in or on Brassica, 

head and stem, subgroup 5A at 0.1 parts 

per million (ppm), pea, southern, dry 

seed at 0.05 ppm, pea, southern, 

succulent seed at 0.05 ppm, pea, 

southern, hay at 0.05 ppm, and rhubarb 

at 0.3 ppm. In addition, the petitioner 

proposes based upon the establishment 

of new tolerances above, removal of the 

existing cabbage tolerance at 0.1 ppm 

under 40 CFR 180.425 that is 

superseded by this action. That 

document referenced a summary of the 

petition prepared by FMC Corporation, 

the registrant, which is available in the 

docket, http://www.regulations.gov. One 

comment was received on the notice of 

filing. EPA’s response to the comment is 

discussed in Unit IV.C. 

Based upon review of data supporting 

the petition, EPA has removed and/or 

established clomazone residue 

tolerances for certain commodities. The 

reason(s) for these changes are 

explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for clomazone 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with clomazone follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

validity, completeness, and reliability as 

well as the relationship of the results of 

the studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

The primary target of clomazone is 

the liver, with hepatocellular 

cytomegaly noted in the chronic rat and 

mouse studies (chronic mouse study 

deemed unacceptable due to maximum 

tolerated dose (MTD) not achieved), 

hepatocellular necrosis in the chronic 

mouse study, and increased liver weight 

observed in subchronic and chronic 

studies. No neurotoxicity studies with 

clomazone are available; however, based 

on a weight of the evidence approach, 

the EPA has concluded that a 

neurotoxicity battery is not required for 

clomazone. This approach considered 

all of the available hazard and exposure 

information including: (1) There is no 

evidence of clinical signs of 

neurotoxicity or neuropathology in 

adult animals in subchronic and chronic 

studies; (2) the liver is the target organ 

for clomazone, not the neurological 

system; (3) clomazone is absorbed and 

rapidly excreted in rats with 97% of the 

radioactivity excreted within 168 hours; 

and (4) the point of departure (POD) and 

endpoint for chronic dietary risk 

assessment is based on liver effects in 

rats which appear to be the most 

sensitive endpoint. There is no 

quantitative or qualitative evidence of 

susceptibility in the developmental 

toxicity study in rabbits or in the 2- 

generation reproduction toxicity study 

in rats. In the developmental toxicity 

study in rats, delayed ossification 

occurred at doses that produced 

maternal effects (chromorhinorrhea and 

abdominogenital staining). Although 

qualitative susceptibility was observed 

in the developmental toxicity study in 

rats, the concern is low since there are 

clear no-observed-adverse-effect-levels 

(NOAELs) and lowest-observed-adverseeffect-levels (LOAELs) in the study and 

this study was used for risk assessment, 

and therefore, is protective of the 

developmental effects. 

There is no concern for mutagenicity. 

In the rat carcinogenicity study, there 

was no evidence of carcinogenicity. The 

mouse carcinogenicity study was 

inadequate to determine carcinogenic 

activity due to the lack of adverse effects 

at the highest dose tested. Despite the 

inadequacy of the mouse 

carcinogenicity study, EPA has 

determined that an additional mouse 

carcinogenicity study is not needed and 

that the rat chronic/carcinogenicity 

study will be adequate for assessing 

chronic risk, including cancer. This 

finding is based upon the following 

conclusions: (1) The rat is more 

sensitive than the mouse for the chronic 

assessment; (2) the consistent effect in 

rats (decreased body weight and 

increased liver weight) has been used as 

the point of departure for the chronic 

assessment; (3) a new mouse study 

would only use doses well above the 

current POD for the chronic assessment; 

and (4) even if a new mouse study 

identified positive carcinogenicity 

effects, that finding would not result in 

the adoption of a quantitative linear 

assessment of cancer risk due to the 

negative carcinogenicity finding in the 

rat study and the lack of a positive 

finding for genotoxicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by clomazone as well as 


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the NOAEL and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in document,’’ 

Clomazone: Human Health Risk 

Assessment for New Uses in/on 

Brassica, Head and Stem, Subgroup 5A; 

Rhubarb; and Pea, Southern (IR–4 

Petition 2E8136)’’, dated December 19, 

2013, pg. 31 in docket ID number EPA– 

HQ–OPP–2013–0056. 

B. Toxicological Points of Departure/

Levels of Concern (LOC) 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological POD and LOC to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for clomazone used for 

human risk assessment is shown in the 

following Table of this unit. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR CLOMAZONE FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario POD and uncertainty/

safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary (general 

population including 

infants and children).

An endpoint was not selected for the general population because no adverse effect in adult animals was identified 

that resulted from a single exposure. A risk assessment is not required for this population subgroup. 

Acute dietary (females 

13–49 years of age).

NOAEL = 100 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute 

RfD = 1.0 mg/kg/day 

aPAD = 1.0 mg/kg/day 

Developmental toxicity study—rat, developmental 

LOAEL = 300 mg/kg/day, based on indications of delayed ossification in the form of either partial ossification or the absence 

of the manubrium, sternebrae 3–4, xiphoid, caudal vertebrae, 

and meta-carpals. 

Chronic dietary (all populations).NOAEL = 84.4 mg/kg/

day (highest dose 

tested).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.84 mg/

kg/day.

cPAD = 0.84 mg/kg/day 

2-year chronic toxicity study—rats, 

NOAEL = 84.4/112.9 mg/kg/day, males/females (highest dose 

tested), 

LOAEL was not attained co-critical 90-day oral rat study 

NOAEL = 135.2/160.9 mg/kg/day, males/females 

LOAEL = 273/319.3 mg/kg/day, males/females, based on decreased body weight, body weight gains, food consumption 

and increased absolute and relative liver weights in females 

and increased absolute liver weights in males. Co-critical 2- 

generation reproduction toxicity study parental 

NOAEL = 50 mg/kg/day parental 

LOAEL = 100 mg/kg/day based on statistically significantly decreased body weight & body weight gain during pre-mating, 

and decreased body weight during gestation & lactation M & 

F. In addition, decreased food consumption in females and 

hydronephritic kidneys in males. 

Cancer (oral, dermal, inhalation).The chronic endpoint is protective against any effects resulting from long-term exposure to clomazone. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). Point of Departure (POD) = A data point or an estimated point that is derived 

from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. 

C. Exposure Assessment 

i. Dietary exposure from food and 

feed uses. In conducting the acute 

dietary exposure assessment EPA used 

the Dietary Exposure Evaluation 

Model—Food Consumption Intake 

Database (DEEM–FCID, ver. 3.16), 

which incorporates consumption 

information from the United States 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). As to 

residue levels in food, EPA incorporated 

tolerance level residues for proposed 

and registered crops, assumed 100 

percent crop treated (PCT) and used 

default processing factors. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the DEEM–FCID, ver. 3.16 

which incorporates consumption 

information from the USDA NHANES/

WWEIA; 2003–2008. As to residue 

levels in food, EPA conducted an 

unrefined assessment that assumed 100 

PCT, used DEEM default processing 

factors, and tolerance-level residues for 

all existing and proposed uses. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that the chronic PAD for 

clomazone will be protective of any 


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cancer risk posed by the pesticide. 

Additionally, EPA is relying on the 

chronic dietary exposure assessment to 

evaluate cancer risk. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for clomazone. 

Tolerance level residues and 100 PCT 

were assumed for all food commodities. 

1. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for clomazone in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of clomazone. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/

water/index.htm. 

The Agency generated the surface 

water estimated drinking water 

concentrations (EDWCs) based on the 

Food Quality Protection Act (FQPA) 

Index Reservoir Screening Tool (FIRST) 

and the Tier 1 Rice Model. Screening 

Concentration in Ground Water (SCI– 

GROW) and Pesticide Root Zone Model 

Ground Water (PRZM GW) models were 

used for ground water EDWCs of 

clomazone. EDWCs were derived based 

on the maximum registered/proposed 

use rate (1.5 pound active ingredient per 

acre (lb ai/A) existing for tuberous and 

corm vegetables and proposed for 

rhubarb) and the maximum registered 

use rate on rice (dry-seeded 0.8 lb ai/A). 

The Tier 1 Rice model (dry-seeded 

scenario) produced the highest EDWCs 

for both acute and chronic exposure. 

The EDWCs of clomazone for acute 

exposures are estimated to be 550 parts 

per billion (ppb) for surface water and 

85.7 ppb for ground water. 

For chronic exposures for non-cancer 

assessments are estimated to be 550 ppb 

for surface water and 77.4 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

both acute and chronic dietary risk 

assessment, the water concentration 

value of 550 ppb was used to assess the 

contribution to drinking water. These 

drinking water estimates account for 

parent plus FMC65317 (N-[(2- 

chlorophenyl)methyl]-3-hydroxy-2,2- 

dimenthylpropanamide) which are the 

residues of concern in drinking water. 

2. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Clomazone is not registered for any 

specific use patterns that would result 

in residential exposure. 

3. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found clomazone to 

share a common mechanism of toxicity 

with any other substances, and 

clomazone does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that clomazone does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www.epa.gov/pesticides/

cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There was no evidence of increased 

quantitative or qualitative susceptibility 

in the prenatal developmental toxicity 

study in rabbits or in the reproductive 

toxicity study in rats with clomazone. In 

the developmental toxicity study in rats, 

effects in the fetuses (delayed 

ossification) occurred at doses that 

produced maternal effects 

(chromorhinorrhea and 

abdominogenital staining) but were 

qualitatively more severe. Although 

qualitative susceptibility was observed 

in the developmental toxicity study in 

rats, the concern is low since there are 

clear NOAELs and LOAELs in this study 

and the NOAEL in the study was used 

as the POD for assessment of acute risk. 

EPA’s assessment of acute risk is 

therefore protective of any 

developmental effects. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for clomazone 

is complete. 

ii. Though there are no acute or 

subchronic neurotoxicity studies 

available for clomazone, there is no 

indication that clomazone is a 

neurotoxic chemical based on results of 

available subchronic, chronic, 

reproductive or developmental toxicity 

studies and no evidence of 

immunotoxicity. EPA concluded, based 

upon its assessment of available data, 

that acute and subchronic neurotoxicity 

studies are not required nor an 

additional uncertainty factor (UFs) 

needed to account for neurotoxicity. 

iii. For the reasons described above, 

there is low concern regarding increased 

susceptibility in the young from 

exposure to clomazone. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to clomazone in 

drinking water. There are no existing or 

pending residential uses. Therefore, 

these assessments will not 

underestimate the exposure and risk 

posed by clomazone. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected for the general population 

including infants and children. 


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Therefore, clomazone is not expected to 

pose an acute risk to these groups. 

An acute endpoint was identified for 

females 13–49 years old due to effects 

observed in fetuses. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

clomazone will occupy 3.0% of the 

aPAD for females 13–49 years old. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to clomazone 

from food and water will utilize 3.6% of 

the cPAD for all Infants < 1 year of age, 

the population group receiving the 

greatest exposure. There are no 

residential uses currently registered or 

proposed for clomazone, and thus no 

chronic exposures from residential use 

of clomazone. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposures take into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Clomazone is not registered for any use 

patterns that would result in short-term 

or intermediate-term residential 

exposures. Because there is no shortterm or intermediate-term residential 

exposure and chronic dietary exposure 

has already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess short-term risk), no further 

assessment of short-term or 

intermediate-term risk is necessary. EPA 

relies on the chronic dietary risk 

assessment for evaluating short-term 

and intermediate-term risk for 

clomazone. Therefore, short-term and 

intermediate-term aggregate risk 

assessments are not required. 

4. Aggregate cancer risk for U.S. 

population. Based on the data 

summarized in Unit III.A., EPA has 

concluded that the cPAD is protective of 

any cancer risk clomazone poses to 

humans. As noted above, chronic 

dietary exposure is 3.6% of the cPAD 

for the highest exposed population 

subgroup. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children, 

from aggregate exposure to clomazone 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography (GC) using a 

nitrogen phosphorus detector (NPD) or 

mass spectrometer (MS)) is available to 

enforce the tolerance expression. 

Samples are acid hydrolyzed, hexane 

extracted, Na2CO3 washed, and cleanedup with a Florisil column. The resulting 

samples are analyzed. The limit of 

quantitation (LOQ) for this method is 

0.05 ppm. A confirmatory procedure 

(GC/MS–SIM) is available (Method I, 

PAM II). 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

There are no Codex MRLs for residues 

of clomazone. 

C. Response to Comments 

One comment was received from 

‘‘American Citizen’’ indicating concerns 

over what he/she believes to be 

unacceptable toxic effects to human 

health, plants, and the environment if 

EPA approves the proposed new uses of 

clomazone. The commenter indicated a 

general opposition to the use of 

pesticides. The commenter also cited 

toxic effects shown in clomazone 

toxicity studies and the alleged 

irrelevance of chronic animal studies to 

chronic human exposure as grounds for 

denying the tolerance petition. 

EPA’s response: The Agency has 

received similar categorical objections 

to the establishment of pesticide 

tolerances from several commenters on 

numerous previous occasions. Refer to 

Federal Register 70 FR 37686 (June 30, 

2005), 70 FR 1354 (January 7, 2005), 69 

FR 63096 (October 29, 2004) for the 

Agency’s response to these types of 

comments. EPA disagrees with the 

commenter’s assertion that a pesticide 

can cause toxic effects at high doses in 

animal studies necessarily means that a 

pesticide tolerance is unsafe. A 

determination on the safety of a 

tolerance must not only consider 

potential toxic effects of the pesticide 

but anticipated pesticide exposure 

levels as well. EPA’s risk assessment did 

just that in finding that there is a 

reasonable certainty that no harm will 

result to the general population, or to 

infants and children, from aggregate 

exposure to clomazone. EPA also 

disagrees with the assertion that chronic 

animal studies are not relevant to 

assessing human risk. Chronic animal 

studies have been relied upon by 

national and international health 

agencies for over 50 years in evaluating 

risks to humans from exposure to 

chemical substances. 

D. Revisions to Petitioned-For 

Tolerances 

After reviewing supporting data and 

information, EPA modified certain 

elements of the petition as proposed in 

the notice of filing, as follows: 

1. EPA corrected the proposed 

commodity definition, ‘‘Brassica, stem 

and head subgroup 5A’’ to read 

‘‘Brassica, head and stem, subgroup 5A’’ 

for consistency in naming of 

commodities, and 

2. In place of the proposed tolerance 

for ‘‘pea, southern, hay’’, EPA is 

establishing tolerances for ‘‘cowpea, 

forage’’, and ‘‘cowpea, hay’’ because 

pea, southern, hay is a very minor feed, 

where as ‘‘cowpea’’ is a type of ‘‘pea, 

southern’’. 

V. Conclusion 

Therefore, tolerances are established 

for residues of clomazone, 2-[(2- 

chlorophenyl)methyl]-4,4-dimethyl-3- 

isoxazolidinone, in or on Brassica, head 

and stem, subgroup 5A at 0.10 ppm; 

cowpea, forage at 0.05 ppm; cowpea, 

hay at 0.05 ppm; pea, southern, dry seed 

at 0.5 ppm; pea, southern, succulent 

seed at 0.05 ppm; and rhubarb at 0.30 

ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 


ehiers on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 79, No. 63 / Wednesday, April 2, 2014 / Rules and Regulations 18461 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children From Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions To Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination With Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: March 21, 2014. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.425 is amended by 

removing the entry for ‘‘Cabbage’’ from 

the table in paragraph (a), and by 

alphabetically adding the following 

entries 

‘‘Brassica, head and stem, subgroup 

5A’’, ‘‘Cowpea, forage’’, ‘‘Cowpea, hay’’, 

‘‘Pea, southern, dry seed’’, ‘‘Pea, 

southern, succulent seed’’, and 

‘‘Rhubarb’’ to the table in paragraph (a) 

to read as follows. 

§ 180.425 Clomazone; tolerances for 

residues. 

(a) General. * * * 

Commodity Parts per 

million 

* * * * * 

Brassica, head and stem, subgroup 5A ................................. 0.10 

* * * * * 

Cowpea, forage .......................... 0.05 

Cowpea, hay ............................... 0.05 

* * * * * 

Pea, southern, dry seed ............. 0.05 

Pea, southern, succulent seed ... 0.05 

* * * * * 

Rhubarb ...................................... 0.30 

* * * * * 

* * * * * 

[FR Doc. 2014–07008 Filed 4–1–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0051; FRL–9907–05] 

Propiconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of propiconazole 

in or on the rapeseed crop subgroup 

20A. Syngenta Crop Protection 

requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective April 

2, 2014. Objections and requests for 

hearings must be received on or before 

June 2, 2014, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0051, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 


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